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High Frequency Oscillation in Pediatric Epilepsy Surgery

Not Applicable
Completed
Conditions
Pediatric Epilepsy
High Frequency Oscillation
Epilepsy Surgery
Interventions
Diagnostic Test: HFO analysis
Registration Number
NCT03790280
Lead Sponsor
University of California, Los Angeles
Brief Summary

High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery guided by the combination of HFO on ECoG and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.

Detailed Description

Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the gold standard.

High frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine if HFO- tailored surgery combining HFOs and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
Inclusion Criteria
  • Age 0-21 years
  • Refractory focal epilepsy
  • Planned resective epilepsy neurosurgery
  • Includes intraoperative or extraoperative electrocorticography with grids
  • Planned resective epilepsy surgery approved by institutional surgery board
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Exclusion Criteria
  • Subjects undergoing non-resective neurosurgery
  • Does not include intraoperative or extraoperative electrocorticography with grids
  • Planned resective surgery is a hemispherectomy/hemispherotomy
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard of Care PLUS HFOHFO analysisSurgery is tailored by HFOs and standard ECoG interpretation (spikes on intra-operative ECoG or seizure onset on extra-operative ECoG) (arm 1).
Primary Outcome Measures
NameTimeMethod
Post-operative Seizure-free Rate1 year after surgery

The primary outcome measure is the number of patients seizure-free after surgery in the treatment arm of combined HFO and standard of care, compared to the number of patients seizure-free in the control arm of standard of care alone, at 1 year after surgery.

Secondary Outcome Measures
NameTimeMethod
Post-operative Complication1 year after surgery

Number of participants experiencing surgical complications

Trial Locations

Locations (1)

University of California, Los Angeles

🇺🇸

Los Angeles, California, United States

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